FDA.reportPublic FDA data

NA

Primary DI
ESOT000801
Brand
NA
Company
S & T AG
Model
CB-1
Catalog number
00080
Device description
CB-1 Clamp Box 70 x 45 mm
Published
2022-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESOT000801PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+41526727407info@s-and-t.net

Regulatory Flags#

DUNS number
481542926
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESOT010801NACB-1.A010802026-01-20
ESOT010751NAICL-1323-0.A010752023-03-01
ESOT011851NAICH-1323-0.A011852023-03-01
ESOT000711NACAF-4 L000712022-09-15
ESOT000721NACAF-4000722022-09-15
ESOT000731NACAF-5 L000732022-09-15
ESOT000741NACAF-5000742022-09-15
ESOT000751NAICL-1323-0000752022-09-15
ESOT000761NAICE-2427-0000762022-09-15
ESOT000821NAB-13-10000822022-09-15
ESOT000831NABL-13-10000832022-09-15
ESOT000841NAB-13-8000842022-09-15
ESOT000851NABL-13-8000852022-09-15
ESOT000861NAB-18-10000862022-09-15
ESOT000871NAB-18-8000872022-09-15
ESOT000881NAC-14000882022-09-15
ESOT000891NACL-14000892022-09-15
ESOT000901NASDC-11000902022-09-15
ESOT000911NASDC-15000912022-09-15
ESOT000921NASDC-15 S000922022-09-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
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00724995296322V. MuellerSteris CorporationFSM2026-08-21
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